This study evaluates CMV/HIV-CAR T cells, a type of immune-cell therapy, as an immunotherapy for people with HIV/AIDS. It enrolls adults aged 18 and older with HIV-1 infection who have been on stable antiretroviral therapy for at least 48 weeks with an undetectable virus level. The study is in Early Phase 1 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Participant must be ≥ 18 years of age at the time of screening; * Karnofsky Performance Status (KPS) ≥ 70; * Documented HIV-1 infection anytime prior to study entry.; * On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable); * CD4+ cell count ≥ 450 cells/μL; * Adequate organ function; * Willingness to interrupt ART regimen for 4 days prior to leukapheresis; * Not pregnant or breastfeeding. Exclusion Criteria: * Concurrent illness or comorbid condition; * History of resistance to two or more classes of antiretroviral drugs; * History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.